Performance Evaluation of Truenat rtPCR assay with COBAS -6800 in SARS COV-2 detection: A diagnostic accuracy study

Context: Diagnostic testing plays a critical role in early and accurate detection of SARS-COV-2. Real-time PCR is the Gold standard test for the diagnosis of SARS-COV-2 which requires well equipped BSL-2 Lab along with skilled manpower. There is a need for a rapid point of care test for diagnosis. TrueNat is one such testing system that is approved by Govt. of India. Aims: To find out the performance of the TrueNat assay in comparison to cobas 6800. Settings and Design: The Cross-sectional study was conducted in a COVID 19 Testing Laboratory in Central India. Methods and Material: A total of 122 COVID-19 positive samples in cobas 6800 were analysed in TrueNat assay. Results: Of the total of cobas positive122 sample TrueNat system were able to detect 116 samples with the viral load of high(n=18), medium(n=28 ), low(n=44),very low(n=26). Considering cobas 6800 as a Gold standard assay TrueNat test showed a sensitivity and specificity of 95% and 100%respectively. Conclusions: Based on our findings we believe that TrueNat assay is equally effective for the diagnosis of SARS-COV-2 compared to a highly sophisticated instrument such as cobas 6800. Hence, it should be installed in all healthcare setups with a limited setting for rapid and reliable diagnosis of SARS-COV-2. Keywords: cobas 6800, TrueNat, COVID-19, Point of care test.